Eli Lilly Submits New Indication Application in China for IL-23 Inhibitor Mirikizumab for Ulcerative Colitis

On April 16, the CDE website showed that Eli Lilly's IL-23 monoclonal antibodyMijizumab（Mirikizumab）A new indication marketing application has been submitted in China. Based on the progress of the drug's clinical research, the new indication for this submission is likely to beUlcerative Colitis。

Screenshot source: CDE official website

Mirikizumab can control inflammation by selectively targeting the p19 subunit of IL-23, blocking its interaction with the IL-23 receptor, and inhibiting the release of pro-inflammatory cytokines and chemokines. In 2023, the drug was successively approved in Japan, the EU, and the United States for the treatment of ulcerative colitis. Since 2025, it has also been approved in Europe, the U.S., and Japan for the treatment of Crohn's disease.

In China, Mirikizumab was first submitted for marketing approval in October last year, with both intravenous and subcutaneous injection formulations simultaneously filed for the treatment ofCrohn's Disease. The new indication for this application is speculated to beUlcerative Colitis。

The FDA approval of mirikizumab for ulcerative colitis was based on the results of the LUCENT program, which aimed to evaluate the efficacy of mirikizumab in moderate to severe active ulcerative colitis.(UC) Efficacy and safety in adult patients. The LUCENT program includes two randomized, double-blind, placebo-controlled Phase III clinical trials: a 12-week induction study.(UC-1) ; the other is a 40-week maintenance study (UC-2), lasting for a total of 52 weeks.

Data show that, in the UC-1 study, after 12 weeks of treatment: Mirikizumab group24% of patients achieved clinical remission.（vs 15%），65% of patients achieved a clinical response (vs 43%), 34% of patients achieved improvement in endoscopy (vs 21%), 25% of patients achieved histological and endoscopic mucosal improvement (vs 14%), both higher than the placebo group.

In the UC-2 study, after 40 weeks of treatment with mirikizumab,51% of patients achieved clinical remission, while the placebo group was 27%. Post-hoc analysis showed that among patients who achieved clinical remission after one year of treatment, 99% had not used steroids for at least the previous 12 weeks.

In addition, 50% of patients in the Mirikizumab group achieved clinical remission without the use of corticosteroids. (vs 27%), 58% of patients showed improvement in endoscopic examination results（vs 30%）Of the patients who achieved clinical remission at week 12, 66% maintained clinical remission.（vs 40%）. Histological and endoscopic mucosal improvement was observed in 43% of patients. (vs 22%）。

Insight database shows that four IL-23 targeted drugs have been approved for marketing in China, respectively:Johnson & Johnson'sGuselkumabAndUstekinumab，Approved for the treatment of plaque psoriasis and Crohn's disease; introduced by Pharmaron ChinaTerecizumab，Approved for the treatment of plaque psoriasis; AbbVie'sLisencekimab, which was just approved for treatment in China this MarchCrohn's Disease。

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